PCPSA's 'No Harm' Standard Would Set High Bar For FDA Ingredient Review

Regulatory consultants have concerns about the draft Personal Care Products Safety Act's proposed standard for FDA ingredient review – reasonable certainty of no harm. The standard's de facto application in FDA's review of new dietary ingredients in the supplement space has resulted in a fail rate of around 75%.

The draft Personal Care Products Safety Act proposes that FDA review cosmetic ingredients against a standard that has proven challenging for the dietary supplement industry and could set unrealistically high consumer expectations, experts suggest.

The bill would require FDA to evaluate the safety of five cosmetic ingredients or non-functional constituents annually, considering whether evidence...

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